For the treatment of
persistent facial erythema associated with rosacea in adults REDUCE
THE REDNESS Help your patients take a step closer to a more normal, healthy skin color1

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, results were seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.

Not an actual patient

Persistent 
facial erythema

Not an actual patient

Persistent facial erythema in adults is the most common sign of rosacea2

  • Approximately 16 million Americans are affected by rosacea3
    • Emergence of persistent facial erythema with a central face distribution is a key to rosacea diagnosis2,4
  • Persistent facial erythema is bothersome for most adult patients with rosacea5
  • May become progressively more persistent and can worsen over time6

RHOFADE® cream is the first and only α1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults1

See RHOFADE® cream
 in action

Lasting results for 12 hours

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.

RHOFADE® cream against vehicle significantly improved persistent facial erythema with lasting results9,10


At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.

Proportions of Subjects With ≥2-Grade Improvement From Baseline (pre-dose on Day 1) in Both CEA and SSA Scores Through 12 Hours on Day 299,10

Trial 1

Hour on Day 29RHOFADE® Cream(N = 222)Vehicle(N = 218)
312%*6%
616%*8%
918%†6%
1215%‡6%

Trial 2

Hour on Day 29RHOFADE® Cream(N = 224)Vehicle(N = 221)
314%*7%
613%‡5%
916%*9%
1212%*6%

*P<0.05; †P<0.001; ‡P<0.01.9,10

CEA = Clinician Erythema Assessment; SSA = Subject Self-Assessment for rosacea facial redness.

Results of 2 identical 29-day, randomized, double-blind, parallel-group, vehicle-controlled trials to evaluate the safety and effectiveness of once-daily RHOFADE® cream in 885 subjects with moderate to severe persistent facial erythema associated with rosacea. The primary endpoint was the proportion of subjects with at least a 2-grade improvement in erythema from baseline (pre-dose on Day 1) on both the CEA and SSA scales measured at hours 3, 6, 9, and 12 on Day 29.1

To achieve composite success, investigators and subjects had to independently rate the change in persistent facial erythema as a 2-grade or greater improvement on similar 5-point scales1

4severe
3moderate
2mild
1almost clear
0clear/no signs of unwanted redness

Composite success was required to meet the primary endpoint1

Proportion of subjects with ≥2-grade improvement in persistent facial erythema1

CEA and SSA scales rate severity of erythema as follows: 4 = severe; 3 = moderate; 2 = mild; 1 = almost clear; 0 = clear/no signs of unwanted redness.11

Before and after

Not an actual patient

RHOFADE® cream significantly improved persistent facial erythema with lasting results
—a step closer to a more normal, healthy skin color1,9,10


At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.

BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.
BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.
BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.
BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.
Unretouched photos of clinical trial subject. Individual results may vary.

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, a ≥2-grade improvement in persistent facial erythema was seen in 12% to 18% of subjects using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain.1 These are not all the possible side effects of RHOFADE® cream. Individual results may vary.

Proven tolerability

Not an actual patient

In pivotal trials, few subjects discontinued due to adverse events
(2.2% with RHOFADE® cream vs 0.4% with vehicle)11

RHOFADE® cream offers proven tolerability11

Adverse Reactions Reported by ≥1% of Subjects Through 4 Weeks of Treatment in Controlled Clinical Trials1§

Adverse ReactionRHOFADE® Cream (N = 489)Vehicle (N = 483)
Application-site dermatitis9 (2%)0
Worsening inflammatory lesions of rosacea7 (1%)1 (<1%)
Application-site pruritus5 (1%)4 (1%)
Application-site erythema5 (1%)2 (<1%)
Application-site pain4 (1%)1 (<1%)
§A total of 489 adult subjects with persistent facial erythema associated with rosacea were treated with RHOFADE® cream once daily for 4 weeks in 3 controlled clinical trials.1

The 52-week, open-label safety trial included 440 subjects1,12

Adverse Reactions Over a 52-Week Treatment Period1,12

Adverse ReactionRHOFADE® Cream (N = 440)
Application-site dermatitis8 (2%)
Application-site paresthesia7 (2%)
Application-site pain5 (1%)
Application-site pruritus5 (1%)
An additional 440 adult subjects with persistent facial erythema associated with rosacea were also treated with RHOFADE® cream once daily for up to 1 year (52 weeks) in a long-term, open-label clinical trial.1,12

Once-a-day,
everyday dosing1
Not for oral, ophthalmic, or intravaginal use.1

Helpful instructions to discuss with your patients:

Apply a pea-sized amount once a day—every day—in a thin layer to cover the entire face (forehead, nose, each cheek, and chin), avoiding the eyes and lips1

Wash hands immediately after application1

Not for oral, ophthalmic, or intravaginal use1
Do not apply RHOFADE® cream to irritated skin or open wounds1

Not an actual patient
Not an actual patient

Keep out of reach of children1
Continue to avoid common triggers13

Patient savings

Patients with commercial insurance may pay as little as $0 to $50 for once-a-day, everyday RHOFADE® cream

PATIENTS MAY PAY AS LITTLE AS$0PER PRESCRIPTION OF RHOFADE® CREAM IF:

  • They have commercial insurance
  • RHOFADE® cream is covered by their plan
  • They have met their deductible

PATIENTS MAY PAY AS LITTLE AS$50PER PRESCRIPTION OF RHOFADE® CREAM IF:

  • They have commercial insurance
  • RHOFADE® cream is not covered by their plan
  • They have not met their deductible
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Patients can text RHOFADE to 97648 or visit savings.rhofade.com to sign up for savings.

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INDICATIONS AND USAGE

RHOFADE® (oxymetazoline hydrochloride, 1%) cream is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain.

MEDICAL INFORMATION and ADVERSE DRUG EVENTS REPORTING

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

For more information, please see full Prescribing Information and Patient Information Leaflet

References

  1. RHOFADE® cream Full Prescribing Information. Novan, Inc. 2023.
  2. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46(4):584-587.
  3. Rosacea now estimated to affect at least 16 million Americans. Rosacea Review. Winter 2010. National Rosacea Society website. www.rosacea.org/rr/2010/winter/article_1.php. Accessed January 13, 2019.
  4. Tan J, Steinhoff M, Berg M, et al. Shortcomings in rosacea diagnosis and classification. Br J Dermatol. 2017;176(1):197-199.
  5. Huynh TT. Burden of disease: the psychosocial impact of rosacea on a patient’s quality of life. Am Health Drug Benefits. 2013;6(6):348-354.
  6. Del Rosso JQ. Advances in understanding and managing rosacea: part 2: the central role, evaluation, and medical management of diffuse and persistent facial erythema of rosacea. J Clin Aesthet Dermatol. 2012;5(3):26-36.
  7. Del Rosso JQ. Advances in understanding and managing rosacea: part 1: connecting the dots between the pathophysiological mechanisms and common clinical features of rosacea with emphasis on vascular changes and facial erythema. J Clin Aesthet Dermatol. 2012;5(3):16-25.
  8. Guimarães S, Moura D. Vascular adrenoceptors: an update. Pharmacol Rev. 2001;53(2):319-356.
  9. Kircik LH, DuBois J, Draelos ZD, et al. Pivotal trial of the efficacy and safety of oxymetazoline cream 1.0% for the treatment of persistent facial erythema associated with rosacea: findings from the first REVEAL trial. J Drugs Dermatol. 2018;17(1):97-105.
  10. Baumann L, Goldberg DJ, Stein Gold L, et al. Pivotal trial of the efficacy and safety of oxymetazoline cream 1.0% for the treatment of persistent facial erythema associated with rosacea: findings from the second REVEAL trial. J Drugs Dermatol. 2018;17(3):290-298.
  11. Data on file. EPI Health, LLC
  12. Draelos ZD, Gold MH, Weiss RA, et al. Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 52-week open label REVEAL trial. J Am Acad Dermatol. 2018;78(6):1156-1163.
  13. Schaller M, Schöfer H, Homey B, et al. Rosacea management: update on general measures and topical treatment options. J Dtsch Dermatol Ges. 2016;14(suppl 6):17-27.